Terms and Conditions

NOTE: These terms and conditions are applicable to sales by Leiters Health to customers. Terms and conditions that are applicable to procurement by Leiters Health of goods and services begin on page 4 below.

1. BASIS OF CONTRACT FOR SUPPLY. Leiters Health shall Supply to Customer, and Customer shall purchase from Leiters Health, Product(s) in accordance with these Conditions, to the exclusion of all other terms and conditions (whether of Customer or otherwise). No order submitted by Customer shall be deemed to be accepted by Leiters Health, no Contract for Supply shall exist, and no obligation or commitment of Leiters Health shall arise, whether in respect of any quotation by Leiters Health or otherwise, unless and until an order submitted by Customer (including a Committed Order) is acknowledged, confirmed, filled or otherwise accepted by Leiters Health, whereupon a Contract incorporating these Conditions shall exist. Unless otherwise agreed in Writing, Leiters Health shall have no obligation to accept any order submitted by Customer. No Special Terms or any other variation to these Conditions or any applicable Contract shall be binding upon Leiters Health unless agreed to in Writing between Customer and Leiters Health, and any Special Terms so agreed upon which contradict these Conditions shall prevail over these Conditions. Definitions of capitalized terms are set forth at the end of these Conditions.

2. QUOTATIONS AND PRICES. Any quotation given by Leiters Health incorporates these Conditions. The price of the Supply of Product(s) shall be Leiters Health’s price in any relevant quotation or, where no price has been quoted (or a quoted price is no longer valid), the price listed in Leiters Health’s published price list existing on the date of Leiters Health’s acceptance of Customer’s order. Unless otherwise agreed in Writing, Leiters Health reserves the right to adjust the price of its Products in its sole discretion from time to time, including without limitation to cover any increases in its cost to Supply. The Parties acknowledge that the prices under these Conditions and/or the Contract may reflect discounts, rebates, or other reductions in price (collectively, “discounts”), and it is their intention that such discounts shall be administered consistent with the discount exception to the federal anti-kickback statute (42 USC 1320a-7b(B)(3)(A)) and the related regulatory discount safe harbor (42 CFR 1001.952(h)). Leiters Health will reflect when a discount applies on invoices or alternative document, and Customer may request additional documentation of purchases and discounts hereunder as necessary to facilitate appropriate reporting. To the extent and as required by Applicable Laws or other contractual obligations, it is Customer’s responsibility to appropriately report or reflect such discounts, including any bundled discounts, on cost reports or claims submitted to third party payors, including but not limited to federal or state health care programs. Further, Customer will retain documentation provided by Leiters Health relating to purchases and discounts hereunder and make it available to federal or state health care program representatives upon request.

3. PURCHASE ORDERS AND COMMITTED ORDERS. Customer is responsible for: (a) the accuracy of the terms in any order; (b) where applicable, ensuring that any Specifications in any quotation from Leiters Health are complete and correct and/or meet the requirements of Customer; and (c) giving Leiters Health accurate, complete and correct information relating to Customer’s requirements for the Supply of Product(s). Each order submitted by Customer shall be deemed to incorporate these Conditions, shall comply with all Applicable Laws, shall be signed by Customer, and shall specify the quantity of each Product to be Supplied, the destination, the price and delivery date, and such other information necessary to effect delivery of each Product. NO ADDITIONAL PRE-PRINTED TERMS OR CONDITIONS CONTAINED IN EITHER PARTY’S PURCHASE ORDERS, ORDER CONFIRMATIONS, INVOICES, QUOTATIONS OR ANY OTHER FORMS SHALL APPLY. Without limiting the generality of the foregoing, a “Committed Order” means an order pursuant to a Written volume commitment, standing order, subscription, or production planning or other forecast then in effect between Customer and Leiters Health (a “Volume Commitment”), subject to the following:(1) unless otherwise agreed in writing by Leiters Health, the lead time between Leiters Health’s initial acceptance of Customer’s Committed Order and the first delivery date will be not less than forty-five (45) days; (2) Customer acknowledges and agrees that it will designate in writing the Committed Order frequency for each Product (e.g., weekly, bi-weekly, or monthly), that failure to do so may be treated by Leiters Health as a bi-weekly designation, and that Leiters Health will rely on such designation, each Committed Order, and the Volume Commitment in its planning, production, and shipping to and for Customer and will automatically fill Committed Orders and invoice Customer accordingly; (3) Customer agrees to purchase not less than ninety percent (90%) of the Volume Commitment; (4) Leiters Health agrees to supply up to one hundred ten percent (110%) of the Volume Commitment (and, if stock is available, to use commercially reasonable efforts to supply more than one hundred ten percent (110%) of the Volume Commitment if ordered by Customer); and (4) Customer may adjust the Volume Commitment and its Committed Order once per calendar quarter upon not less than forty-five (45) calendar days’ prior written notice to Leiters Health (provided that if any such adjustment is greater than twenty percent (20%) with respect to either (x) any Product or (y) the aggregate quantity of Products or dollar amount, the portion in excess of twenty percent (20%) shall require the written approval of Leiters Health). For administrative convenience, Leiters Health reserves the right to calculate and implement Volume Commitment and Committed Order adjustments according to the number of product packs (e.g., five units per pack, 10 units per pack, etc.). In addition, if Customer’s pricing is based on Customer’s designation of a pricing tier from multiple tiers tied to different purchase volume ranges (e.g., access tier pricing, committed tier pricing, etc.), and if Customer designates any tier (a “Committed Tier”) with pricing lower than the “access tier,” Customer thereby agrees that: (A) in exchange for such Committed Tier pricing, Customer shall purchase from Leiters Health not less than the purchase volume required to be eligible for such pricing; and (B) at any time after the first ninety (90) days following the later of (as applicable) the effective date of Customer’s designation or the first day of the contract year for which a still-current Committed Tier designation remains in effect, if Customer’s purchases for the relevant purchasing period, measured as of the then-most recent calendar month-end, do not meet or exceed the required purchase volume (determined on a pro rata basis if the relevant purchasing period is less than a full contract year, Leiters Health reserves the right, on five (5) business days’ prior written notice and as a non-exclusive remedy, to re-designate and adjust Customer’s pricing prospectively to the applicable pricing tier for Customer’s actual purchase volume from the relevant measurement period.

4. DELIVERY. Leiters Health shall deliver Product to Customer FOB the Facility. Except as otherwise provided in Writing or an applicable Leiters Health promotion, Customer shall be responsible for all freight, import/export, broker, duty, fee, and tax costs associated with shipping Product from the Facility to Customer’s designated location. Title to and all risk of loss of or damage to Product shall pass to Customer upon delivery. Any dates quoted or agreed for delivery of Product are approximate only (except pursuant to an order, including a Committed Order, submitted and accepted at least thirty (30) days prior to the requested delivery date or unless otherwise agreed in Writing), and Leiters Health shall not be liable for any delay in delivery caused by events or circumstances beyond Leiters Health’s reasonable control.

5. COMPONENTS. If any component of compounding, repackaging, or other Supply services is to be supplied to Leiters Health by Customer or Customer’s distributor or supplier of such component (for example, Avastin®), then: (a) any such component that is itself an approved finished human drug product (i) shall have been purchased either (A) directly from a manufacturer who has registered and is listed with FDA under Section 510 of the Act, without repacking or other alteration since initial manufacture, or (B) from a distributor that certifies that such component has not been subject to repacking or other alteration since initial manufacture, and (ii) shall have been stored in compliance with, and shipped to Leiters Health under conditions that comply with, all labeling specifications and requirements for such component; (b) such component shall be delivered to Leiters Health FOB the Facility; (c) Customer (or, if applicable, Customer’s distributor or supplier) shall be responsible for all freight, import/export, broker, duty, fee, and tax costs associated with shipping such component to the Facility and shall bear all risk of loss of or damage to such component while in transit; (d) Leiters Health reserves the right, without notice, to reject such component and return it to Customer, at Customer’s sole expense (or, if applicable, to Customer’s distributor or supplier at such distributor’s or supplier’s sole expense) and without liability to Leiters Health, if such component fails to comply with or satisfy any requirement of clause (a) above or if the expiration date or beyond-use-date of any such component is insufficient to allow the Product that is to be Supplied by Leiters Health to have an expiration date or beyond-use-date that complies with Applicable Laws or the applicable Leiters Health Standard Operating Procedures for quality and dating of such Product; and (e) excess quantities of such component (if any) shall become the property and responsibility of Leiters Health to be used and/or disposed of by Leiters Health in its sole discretion without remuneration to Customer (but in any case in compliance with Applicable Laws). If any component of compounding, repackaging, or other Supply services is itself an approved finished human drug product (for example, Avastin®) that is required for such Supply services and is not to be supplied to Leiters Health by Customer or Customer’s distributor or supplier of such component: (x) Leiters Health will use commercially reasonable efforts to procure such component; (y) notwithstanding any volume commitment of Customer, any supply commitment by Leiters Health, or any provision of these Conditions or any Contract or Special Terms, in no event does or shall Leiters Health guarantee or be understood or deemed to have guaranteed the supply or availability of such component from any manufacturer, distributor, or other supplier thereof; and (z) provided that Leiters Health has used its commercially reasonable efforts in good faith as provided in the foregoing clause (x), Leiters Health shall have no liability for any failure or inability to Supply that results, directly or indirectly, in whole or in part, from the failure, refusal, or inability of any such manufacturer, distributor, or other supplier of such component to supply the same to Leiters Health (and, in that case, Leiters Health and Customer shall cooperate in good faith and use commercially reasonable efforts to work together on alternative means to obtain such component, including but not limited to as contemplated by the first sentence of this Section 3). Notwithstanding any provision of these Conditions or any Contract or Special Terms, Leiters Health reserves the right to pass through to Customer any increase in Leiters Health’s cost to procure any component of compounding, repackaging, or other Supply services that is itself an approved finished human drug product.

6. INCREASES IN COST OF SUPPLY. Without limitation of Leiters Health’s right to adjust the price of its Products in its sole discretion from time to time, unless otherwise agreed by Leiters Health in Writing: (a) Leiters Health reserves the right to pass through to Customer any increase in Leiters Health’s cost to procure any component of compounding, repackaging, or other Supply services that is itself an approved finished human drug product; and (b) if at any time there is a change in market conditions, including without limitation an increase in Leiters Health’s cost of active pharmaceutical ingredient or other components of supply, that results in (or that is reasonably anticipated to result in) an increase in Leiters Health’s cost to Supply any Product of at least five percent (5%), Leiters Health may, at its option, provide written notice of such cost increase to Customer (which notice shall include a reasonably detailed description of such cost increase and supporting documentation), and the price of such Product shall be increased by the amount of such cost increase effective thirty (30) days following the date of the above-described notice of cost increase from Leiters Health to Customer.

7. INSPECTION, ACCEPTANCE, AND REJECTION OF PRODUCTS. Customer will have 48 hours from delivery to inspect Products (the “Inspection Period”). Any Product not compliant with the Specifications or Applicable Laws shall be deemed a “Defective Product”. If Customer intends to reject Products because such Products are Defective Products, it shall give notice in Writing within 24 hours after the Inspection Period expires; otherwise, Products shall be deemed accepted and may not be returned for any reason. Leiters Health will, at Customer’s option, either promptly replace at its cost any Defective Product or credit or refund any payments made by Customer for such Defective Product.

8. INVOICES. Leiters Health shall invoice Customer upon delivery as provided above. Customer shall pay the amount of each invoice within thirty (30) days of the date of invoice (with interest on past due amounts at the rate of 1.5% per month). Payment will be credited when the funds paid are available to Leiters Health without any restriction relating to the collectability of the funds received from Customer. Surcharges may apply if Customer pays by credit card. If at any time, in Leiters Health’s sole discretion, Customer’s credit is impaired, Leiters Health shall have the right to require payment in advance before making any further shipment of Products. If Customer shall fail, within a reasonable time, to make such payment in advance, or if Customer shall fail to make payment when due, Leiters Health shall have the right, at its option, to suspend further deliveries hereunder until such failure is corrected, without thereby releasing Customer from its obligations under the Contract.

9. FAILURE TO TAKE DELIVERY. If Customer fails or refuses to take delivery, Customer shall be billed at that time for all unshipped Product, and on the first of each month thereafter for reasonable administration and storage costs. For each such shipment of undelivered Product, Customer agrees that: (a) Customer has made a fixed commitment to purchase such Product; (b) risk of ownership for such Product shall be borne by Customer; (c) such Product shall be on a bill-and-hold basis for legitimate business purposes; and (d) if no delivery date is determined at the time of billing, Leiters Health shall have the right to ship such Product at or after billing.

10. RECALLS. In the event that a recall, withdrawal or field correction of any Product (a “Recall”) is initiated, whether by a statutory or Regulatory Authority in any jurisdiction (including the FDA, state boards of pharmacy, and state-controlled substance boards), Leiters Health shall comply with all requirements of such statutory or Regulatory Authority with respect to such Recall (provided that Customer shall reasonably cooperate with Leiters Health in connection with any Recall).

11. MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents, warrants, and covenants to the other Party as follows: (a) such Party is and will remain duly organized, validly existing, and in good standing under the laws of the state in which it is organized, has and will continue to have the power and authority and legal right to own and operate its property and assets and to carry on its business as it is now being conducted, and does and will exercise its rights and perform its obligations hereunder in compliance with all requirements of Applicable Laws; (b) such Party has and will continue to have the power and authority and the legal right to enter into the Contract and to perform its obligations thereunder and has taken all necessary action on its part to authorize the execution and delivery of the Contract and the performance of its obligations thereunder; (c) the Contract has been duly executed and delivered on behalf of such Party and constitutes the legal, valid, and binding obligation of such Party enforceable against such Party in accordance with its terms; (d) all necessary consents, approvals, and authorizations of Regulatory Authorities and any other third parties required to be obtained by such Party in connection with the execution, delivery, and performance of the Contract by such Party have been obtained; and (e) the execution and delivery of the Contract by such Party, the exercise by such Party of its rights thereunder, and the performance by such Party of its obligations thereunder do not and will not contravene or conflict with such Party’s organizational documents, contravene or conflict with or constitute a violation of any Applicable Laws, or breach or constitute a default under or conflict with the provisions of any contract, agreement or instrument to which it is a party or by which it is bound.

12. REPRESENTATIONS AND WARRANTIES OF LEITERS HEALTH. Leiters Health hereby represents, warrants and covenants as follows: (a) Leiters Health has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations necessary to Supply the Product(s) in compliance with Applicable Laws; (b) all Product(s) delivered to Customer hereunder shall have been Supplied by Leiters Health in compliance with these Conditions, the Specifications, cGMP, and all Applicable Laws; and (c) Leiters Health has and will convey to Customer good title to all Product(s), free from any security interest, restriction, reservation, lien, or other encumbrance whatsoever. In furtherance of the foregoing clause (b), if Customer submits an order for a Product that does not appear on the drug shortage list in effect under Section 506E of the Act at the time of Supply or the time of dispensing by Customer, and of which the bulk drug substance is also a component of an FDA-approved drug or a Covered OTC Drug Product (as defined below), such that Leiters Health reasonably believes that it is required by Applicable Law to obtain an assurance, either from Customer or its prescribing health care practitioner, to the effect that such Product will be administered or dispensed only to patients for whom the change between the Product and the FDA-approved drug (or Covered OTC Drug Product) produces a clinical difference, as determined by such prescribing health care practitioner, Customer agrees that it will provide (and will be able to provide on behalf of such prescribing health care practitioner) such assurance in writing either on the order form for such Product or promptly following Leiters Health’s request. For this purpose, “Covered OTC Drug Product” means any marketed drug not subject to Section 503(b) of the Act (i.e., non-prescription drugs) and not subject to approval in an application submitted under Section 505 of the Act.

13. REPRESENTATIONS AND WARRANTIES OF CUSTOMER. Customer hereby represents, warrants, and covenants to Leiters Health as follows: (a) Customer has and shall maintain in good standing all required regulatory clearances, approvals, licenses, permits, and other authorizations (“Licenses”) necessary to order, possess, prescribe, administer, dispense, and/or dispose of the Product(s), as applicable, in compliance with Applicable Laws and shall order, possess, prescribe, administer, dispense, dispose of, and otherwise use the Product(s) properly, in compliance with Applicable Laws, and in conformity with sound professional medical practice and judgment (including if prescribed, administered, dispensed, and/or otherwise used off-label); (b) Customer shall not engage in any sale or transfer of any Product in violation of the “own use” restrictions set forth in Section 503B(a)(8) of the Act (21 U.S.C. 353b(a)(8)); and (c) Customer has and shall maintain in full force and effect insurance coverages (including carriers of such insurance) that are reasonable, appropriate, and sufficient for the business of Customer and the risks of its business and operations and shall provide to Leiters Health, promptly upon Leiters Health’s request, a certificate or other satisfactory proof evidencing such insurance (which certificate, if reasonably requested by Leiters Health, shall also name Leiters Health as an additional insured). Each order submitted by Customer shall constitute Customer’s certification that each of its representations and warranties set forth in these Conditions is then true (and shall remain true throughout performance of the Contract), and, promptly following written request by Leiters Health with respect to any License, Customer shall provide Leiters Health with verification from the applicable Regulatory Authority that such License is active and in good standing. Subject to compliance by Leiters Health with the opt-out requirements and other applicable provisions of the CAN-SPAM Act (Controlling the Assault of Non-Solicited Pornography and Marketing Act of 2003, as amended, 15 U.S.C. 7701-7713), Customer consents to receiving unsolicited commercial e-mail messages from Leiters Health for the advertisement or promotion of Leiters Health’s products or services.


15. INDEMNIFICATION. Each of Leiters Health and Customer (in either case, the “Indemnifying Party”) shall indemnify and hold harmless the other Party and its directors, officers, employees, Affiliates, stockholders, members, agents, attorneys, representatives, successors and assigns (collectively, the “Indemnified Parties”) from and against any and all losses, damages, costs and expenses (including reasonable attorneys’ fees) (“Losses”) arising from or in connection with any claim, demand, assessment, action, suit or proceeding by any third party (a “Claim”) suffered or incurred by any Indemnified Party arising out of or resulting from: (a) any misrepresentation or breach of warranty made by the Indemnifying Party in the Contract; (b) any breach of any covenant or agreement made or to be performed by the Indemnifying Party pursuant to this Contract; or (c) the negligence or willful misconduct of the Indemnifying Party; except in each case, to the extent any such Loss arises out of or results from any Indemnified Party’s negligence, willful misconduct, or breach of the Contract. Without limiting the generality of the foregoing, Customer, as the Indemnifying Party, shall indemnify and hold harmless the Leiters Health Indemnified Parties from and against any and all Losses arising from or in connection with any Claim suffered or incurred by any Leiters Health Indemnified Party arising out of or resulting from the possession, prescription, administration, dispensing, disposal, or other use of any Product that is Supplied by Leiters Health hereunder in compliance with cGMP and Applicable Laws.


17. TERMINATION. Unless otherwise agreed in Writing: (a) a Party may immediately terminate the Contract by written notice if the other Party materially breaches any provision of the Contract and such breach is not cured within thirty (30) calendar days after receipt of Written notice identifying such breach; (b) a Party may immediately terminate the Contract by Written notice if the other Party has been unable to perform its obligations for ninety (90) consecutive calendar days by reason of Force Majeure; (c) a Party may immediately terminate the Contract by Written notice in the event that (i) a bankruptcy petition is filed against the other Party or a receiver, trustee, or other custodian is appointed for all or any substantial portion of the assets or business of the other Party that is not dismissed within thirty (30) days from the date of such filing or appointment; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by such other Party; (iii) the other Party suffers or permits the entry of an order adjudicating it to be bankrupt or insolvent and such order is not discharged within thirty (30) days; or (iv) such other Party enters into an agreement with its creditors or makes an assignment for the benefit of creditors; and (d) Leiters Health may terminate the Contract upon ninety (90) days Written notice to Customer (or, if termination of the Contract in its entirety or only with respect to one or more Products is, in Leiters Health’s sole and absolute discretion, necessitated by a Regulatory Change (as defined below), then upon thirty (30) days Written notice to Customer or less to the extent necessary for Leiters Health to comply with such Regulatory Change). The term “Regulatory Change” means any change in, under, or pursuant to Applicable Laws (including without limitation a cease and desist notification or any other change resulting in a 503B compounded drug or service no longer being permissible under or pursuant to Applicable Laws) that makes or in Leiters Health’s sole and absolute discretion is reasonably likely to make Leiters Health’s performance of its obligations under the Contract (or any portion thereof) with respect to the affected Product or Products, or the manner in which Leiters Health performs or is to perform such obligations, unlawful.

18. CONFIDENTIALITY. (a) Customer shall not use Confidential Information for any purpose other than to the limited extent necessary to carry out the Contract, shall protect Confidential Information with the same degree of security afforded Customer’s own proprietary information and, in all events, with reasonable care, and shall not disclose Confidential Information to any third party (except that Customer may disclose Confidential Information upon receipt of specific prior written consent from Leiters Health or if Customer is legally compelled to disclose the Confidential Information and Customer provides reasonable advance notice to Leiters Health). (b) The obligations created by the foregoing clause (a) shall not apply to particular Confidential Information if Customer can reasonably demonstrate such Confidential Information is in the public domain at the time of disclosure thereof by Leiters Health to Customer, becomes publicly available subsequent to disclosure thereof by Leiters Health without Customer’s breach of any obligations owed to Leiters Health, became known by Customer at any time from a source other than Leiters Health and other than by breach of an obligation of confidentiality owed to Leiters Health, was otherwise known by Customer prior to disclosure thereof by Leiters Health to Customer, or was independently developed by Customer without reference to, exposure to, use of, or disclosure of any Confidential Information. (c) Following performance or termination of the Contract, Customer shall, upon request, promptly return or destroy all tangible items in its possession containing Confidential Information, delete all electronic media containing Confidential Information, and (if requested) certify to Leiters Health in writing that it has complied with the obligations of this clause (c) (provided that, for the sole purpose of evidencing compliance with this Section, Customer may maintain a secure file containing a single copy of all items returned to Leiters Health). (d) If Customer breaches this Section, then Leiters Health shall, without being required to demonstrate damage or irreparable harm, be entitled to a temporary restraining order, preliminary and permanent injunction, specific performance and other equitable relief as necessary to enjoin or equitably remedy the conduct in breach, and the availability or election of equitable remedies shall be in addition and without prejudice to any other remedies available to Leiters Health. (e) This Section does not grant any license or transfer any property interest to Customer or obligate Leiters Health to disclose any Confidential Information to Customer. (f) Obligations created by this Section shall survive the performance or termination of the Contract for a period of five years.

19. ASSIGNMENT. Leiters Health may assign the Contract or any part of it, or subcontract any of its obligations under the Contract, to any person, firm or entity (including, by way of illustration and not limitation, to a Leiters Health Affiliate operating a Facility at which a Customer order may be filled). Customer shall not be entitled to assign the Contract or any part of it without the prior written consent of Leiters Health.

20. NOTICES. Any notice required or permitted to be given by either Party to the other shall be in Writing addressed to the other Party at its registered office or principal place of business or such other address as may at the relevant time have been provided pursuant to this provision to the Party giving the notice and shall be effective on the business day of actual receipt or, if received otherwise than on a business day, on the next business day.

21. WAIVER. No delay on the part of Leiters Health or Customer in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of either Party of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder, nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder. Any provision of the Contract may be waived if, and only if, such waiver is in Writing and signed by the Party against whom the waiver is to be effective.

22. SEVERABILITY. If any provision of these Conditions is held by any competent authority to be invalid or unenforceable in whole or in part, the validity of the other provisions of these Conditions and the remainder of the provision in question shall not be affected thereby.

23. ENTIRE AGREEMENT. The Contract constitutes the entire agreement between the Parties with respect to the subject matter thereof and supersedes all prior agreements, understandings and negotiations, both written and oral, between the Parties with respect to the subject matter of the Contract.

24. GOVERNING LAW. The Contract shall be governed by and construed in accordance with the laws of the State of Delaware excluding any choice of law rules which may direct the application of the law of another state.

25. FORCE MAJEURE. Neither Party will be liable to the other for any failure or delay in performance (other than such Party’s payment obligations hereunder) if the failure or delay is due to an act of God, war, riot, revolution, fire, explosion, sabotage, terrorism, accident, casualty, or other cause not within the reasonable control of the Party claiming a Force Majeure situation. Without limiting the generality of the foregoing, “Force Majeure” with respect to Leiters Health shall include shortage or unavailability of supply of drug products or active pharmaceutical ingredients resulting from any of the foregoing occurrences and/or similar events of equal magnitude otherwise outside of Leiters Health’s reasonable control.

26. DEFINITIONS. As used herein: (a) “Act” means the U.S. Food, Drug, and Cosmetic Act, as amended; (b) “Affiliate” of a party means any corporation, firm, partnership, or other entity which controls, is controlled by, or is under common control with such party (and, for purposes of this definition, “control” means the ownership of more than fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest); (c) “Applicable Laws” with respect to a Party means the international, federal, state, and local laws, statutes, codes, ordinances, rules and regulations, and interpretations of any agency, government, authority, commission, board, bureau, or administrative or other entity, body, or Regulatory Authority (including without limitation any then-most-current FDA guidance documents) that are applicable to the conduct of such Party’s business and the performance of such Party’s obligations hereunder; (d) “cGMP” means FDA’s current Good Manufacturing Practices as promulgated under the Act at 21 CFR (parts 210 and 211), and as further defined by then-most-current FDA guidance documents, in each case as applicable to the compounding, manufacture, packaging, handling and storage of Product(s); (e) “Conditions” means these Standard Terms and Conditions for the Supply of 503B Products and Services; (f) “Confidential Information” means Leiters Health’s information regarding its products, business and technology that is not readily available to the public, whether in tangible or intangible form, including but not limited to market information, prices and pricing structure, in-depth product and process knowledge, trade secrets, supplier and customer information, technical data and specifications; contractual relationships; business methods; market data; financial data; projections; strategies; intellectual property rights, including trademarks, patents and copyrights; and the Contract; in each case which is not generally available or disclosed to the public or which is marked or labeled “Proprietary and Confidential”; (g) “Contract” means an agreement in Writing between Customer and Leiters Health pursuant to which Leiters Health Supplies Product(s) to Customer in accordance with these Conditions and any Special Terms; (h) “Facility” means and refers to any FDA-registered 503B outsourcing facility operated by Leiters Health or any of its Affiliates, including without limitation each such facility registered in the name of Denver Solutions, LLC d.b.a. Leiters Health and located at (1) 13796 Compark Boulevard, Englewood, Colorado 80112, and (2) 101-105 Lincoln Avenue, Buena, NJ 08310; (i) “FDA” means the U.S. Food and Drug Administration; (j) “Leiters Health” means Denver Solutions, LLC, a Delaware limited liability company d.b.a. Leiters Health; (k) “Product” means the drug preparation, product, or related service (or any combination thereof) that is the subject of a Leiters Health quotation and/or Customer order, as contemplated by these Conditions; (l) “Regulatory Authority” means any federal, national, supranational, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the testing, compounding, packaging, repackaging, manufacture, use, storage, import, promotion, marketing and sale of a Product in a country; (m) “Special Terms” means any special terms and conditions of the Contract agreed in Writing by Customer and Leiters Health; (n) “Specifications” means Customer’s specifications for the Product(s) set forth in the applicable order (or in a Leiters Health quotation upon which such order is based); (o) “Supply” means the compounding, manufacturing, packaging, repackaging, labeling, quality control, testing, preparing for shipment and selling of Products; and (p) “Writing” means any written communication (including fax and e-mail) between Leiters Health and Customer.